Clinical Research Coordinator Head/Neck Team

Company: University of Colorado
Location: Aurora
Posted on: September 22, 2022

Job Description:

Clinical Research Coordinator Head/Neck Team - 26895 University StaffDescriptionUniversity of Colorado Anschutz Medical CampusSchool of Medicine, Cancer CenterCancer Clinical Trials Office (CCTO)Research Services Professional (Entry, Intermediate, or Senior Open Rank)Clinical Research Coordinator (Level I, II, or III Open Rank)Head/Neck Team

• Applications are accepted electronically ONLY at www.cu.edu/cu-careers (https://apptrkr.com/get_redirect.php?id=3315095&targetURL=http://www.cu.edu/cu-careers) *The University of Colorado has a requirement for COVID-19 vaccinations and full completion thereof by 9/1/21 or upon start date. Information regarding this requirement, and exemptions can be found at:Anschutz: https://www.ucdenver.edu/docs/librariesprovider284/default-document-library/3000-general-admission/3012---covid-19-vaccination-requirement-and-compliance.pdf?sfvrsn=4e9df3ba_2Denver: https://www.ucdenver.edu/coronavirus (https://apptrkr.com/get_redirect.php?id=3315095&targetURL=https://www.ucdenver.edu/coronavirus)Exemptions vary by campus location/department.Campus/Unit-Specific Exemptions:
  • Anschutz Campus Exemptions are allowed for medical or religious reasons.
  • Denver Campus - Exemptions are allowed for medical, religious, or personal reasons.
  • Consolidated/Central Services Administration Will follow Anschutz policy on exemptions.The University of Colorado Cancer Center (https://apptrkr.com/get_redirect.php?id=3315095&targetURL=https://medschool.cuanschutz.edu/colorado-cancer-center) is Colorado's only National Cancer Institute (NCI) designated Comprehensive Cancer Center, a distinction recognizing its outstanding contributions to research, clinical trials, prevention, and cancer control. The CU Cancer Center's vision is to "prevent and conquer cancer. Together." We do this through our mission statement of "uniting our community to overcome cancer through innovation, discovery, prevention, early detection, multidisciplinary care, and education." Our more than 300 renowned physicians and researchers conduct patient-centered research to develop innovative, state-of-the-art technologies, and treatments. Our expertise across cancer types helps us provide world-class treatment for common cancers, while offering hope for many patients with difficult or aggressive tumors who have struggled to find treatment options elsewhere.As an important member of the research team, the Clinical Research Coordinator works with Phase I-IV industry-sponsored, co-operative group and or investigator-initiated clinical trials in accordance with the trial protocols, FDA Regulations, and ICH/GCP Guidelines. This position is accountable for meeting study-specific goals and timelines, while also performing and assisting with clinical tasks related to study-specific tests, procedures, and treatments as assigned based on appropriate licensure and/or completion of competency documentation and team needs. This position is responsible for coordinating study subject appointments throughout the study as well as scheduling, coordinating, and preparing for monitoring visits and audits. The incumbent is responsible for data entry and resolution, study subject advocacy; and possible management of studies at the local level. This position communicates appropriately and effectively with study subjects, investigators, and other team members and has outstanding customer service skills and accepts responsibility in maintaining relationships that are equally respectful to all.Examples of Work Performed by the Clinical Research Coordinator (all levels)
    • Obtains study subject medical history and current medication information, reviews research protocol Inclusion/Exclusion Criteria, and confirms eligibility of subject to participate in clinical trial.
    • Performs informed consent process or ensures that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required
    • Interviews prospective subjects for a variety of research clinical trials. Educates potential subjects on the details of the studies through phone contacts and personal interviews
    • Schedules subject participation in research clinical trial, coordinating availability of necessary space, and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy)
    • Collaborates with hospital staff to ensure tests and procedures, required by research protocols, are performed and documented (e.g., vital signs, phlebotomy, specimen processing, electrocardiograms (EKGs), research drug administration, and protocol-specific tests and procedures)
    • Research specimen collection, processing and shipping, develops protocol-specific source documents (e.g., data collection tools, study visit checklists, pharmacokinetic sample collection worksheets, etc.)
    • Reports subject Adverse Events (AEs) and Serious Adverse Events (SAEs) to appropriate parties (e.g., Principal Investigator, Study Sponsor, Food and Drug Administration (FDA), Data and Safety Monitoring Committee (DSMC), Regulatory Affairs Coordinator, etc.)
    • Familiar with protocol and all study documents and reviews documents after each study subject visit for completeness and accuracy
    • Abstracts and records all research subject data pertaining to the research protocol onto protocol-specific Case Report Forms (CRFs) and into the Cancer Center clinical trials database in an accurate and timely fashion
    • Ensures complete source documentation is compiled for each study subject record
    • Collaborates with Clinical Research Staff in obtaining toxicity grading levels, including assessment of clinical significance of all lab and test results and relatedness of adverse reactions according to protocol guidelines
    • Schedules, coordinates, and prepares for Sponsor Monitor Visits and audits in collaboration with the CCTO Regulatory Affairs, Primary CRC and other research team members
    • Meets with Monitors to respond to any question of data validity and corrects/revises data as appropriate; responds to queries from Sponsor
    • Assists with Sponsor, Data Safety Monitoring, and Food and Drug Administration (FDA) audits and responses
    • Coordinates and assists with completion of study specific logs (delegation, enrollment, etc.)
    • Works on multiple research studies simultaneously
    • Conducts follow-up of study patients
    • Performs clinical duties as assigned based on appropriate licensure and/or completion of competency documentation
    • Independently coordinates and manages data entry, queries, and monitor visits
    • Assists Team Manager and/or Financial Team by processing bills and/or answering billing questions related to procedure performed for subjects enrolled in clinical trials
    • Serves as Primary Coordinator for clinical trials
    • Completes administrative tasks requested by Supervisor/Manager, as necessary
    • Serves as contact person to study sponsor for ongoing clinical research studies
    • Coordinates and meets data deadlinesAdditional Duties Performed by Clinical Research Coordinator (Level II Intermediate)
      • Assists Team Supervisor with creation of training process documents and conduct of process and quality improvement projects
      • Trains, assesses, and mentors new Clinical Coordinators, as directed by Supervisor/Manager
      • Possesses an understanding of clinical research history, regulations, and ethicsAdditional Duties Performed by Clinical Research Coordinator (Level III Senior)
        • Identifies data trends and deficiencies and works with corresponding personnel in a process improvement manner.
        • Works with clinical providers and clinic staff to ensure source documentation is at the highest level.
        • Performs additional duties as assigned by team supervisor and manager
        • Serves as role model to all Clinical Research CoordinatorsMinimum Qualifications:Clinical Research Coordinator CRC I Level
          • Bachelor's degree in Science, Health, Business or Finance, Mathematics, History, Social Sciences, Arts, Communications, Education, Engineering, Human Services, Legal, or related fieldsSubstitution: Any equivalent combination of relevant Education and Experience can substitute for the degree on a year-for-year basis.Clinical Research Coordinator - CRC II Level
            • Bachelor's degree in Science, Health, Business or Finance, Mathematics, History, Social Sciences, Arts, Communications, Education, Engineering, Human Services, Legal, or related fields
            • One (1) year of clinical research experience and one (1) year of clinical and/or research experience.Substitution: Any equivalent combination of relevant Education and Experience can substitute for the degree on a year-for-year basis.Clinical Research Coordinator - CRC III Level
              • Bachelor's degree in Science, Health, Business or Finance, Mathematics, History, Social Sciences, Arts, Communications, Education, Engineering, Human Services, Legal, or related fields
              • Two (2) years of clinical research experience and one (1) year of clinical and/or research experience.Substitution: Any equivalent combination of relevant Education and Experience can substitute for the degree on a year-for-year basis.Preferred Qualifications:
                • Knowledge of and experience with basic human anatomy, physiology, and medical terminology.
                • Oncology research experience
                • Intermediate to Advanced Microsoft Office skills (Excel, Word, Outlook).
                • Experience working with an assortment of electronic CRF software programs
                • Experience with Sponsors and Audits
                • Additional certification (one of the following):
                • CCRC Certified Clinical Research Coordinator
                • CCRP Certified Clinical Research Professional
                • CCRA Certified Clinical Research AssociateCondition of Employment:Individual must obtain and track continuing education regardless of whether they have an additional certification (required annual levels):
                  • CRC I 5 CEUs
                  • CRC II 10 CEUs
                  • CRC III 15 CEUsKnowledge, Skills, and Abilities (all levels):
                    • Analytical Skills - Ability to interpret and master complex research protocol information.
                    • Attention to Detail Excellent attention to detail and ability to interpret and master complex research protocol information
                    • Complex Problem Solving Identifies complex problems and reviews related information to develop and evaluate options and implement solutions.
                    • Communication Skills - Good command of the English language, and ability to communicate effectively, both written and verbal.
                    • Interpersonal Skills Ability to establish and maintain effective working relationships with employees at all level; interacts with people in a friendly, open, honest manner; models a commitment to teamwork; demonstrates respect for the opinions of others; and maintains high level of confidentiality.
                    • Customer Service Demonstrates a commitment to excellent customer service, providing internal and external customers with information or assistance in resolving problems.
                    • Adaptability Adapts quickly to change and is able to manage multiple priorities and deadlines in a calm, organized manner; is open to new ideas and methods; is able to work independently and as part of a team.
                    • Planning and Organizing Sets priorities, anticipates obstacles when planning ahead, manages time effectively to accomplish tasks.
                    • Technical Skills Adept at utilizing technology to effectively communicate and complete work (e.g. MS Outlook, MS Word, MS Excel); ability to learn new technology.(NOTE: Career family definition, level definition and position emphasis in the job description above will be included in posting here.)This description is a summary only and is describing the general level of work being performed, it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business need. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.Required: Applicants must meet minimum qualifications at the time of hire.Salary and Benefits:The salary ranges for this position has been established at:Level I (Entry) $44,403-$49,500Level II (Intermediate) $48,321-$54,500Level III (Senior) $52,239-$60,000Actual salary is commensurate with skills and experience.The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialty, and training.The above salary range ( or hiring range ) represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.This position is not eligible for overtime compensation.Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.Benefits: https://www.cu.edu/employee-services/benefits (https://apptrkr.com/get_redirect.php?id=3315095&targetURL=https://www.cu.edu/employee-services/benefits)Total Compensation Calculator: http://www.cu.edu/node/153125 (https://apptrkr.com/get_redirect.php?id=3315095&targetURL=http://www.cu.edu/node/153125)Diversity and Equity:The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@ucdenver.edu (https://apptrkr.com/get_redirect.php?id=3315095&targetURL=hr.adacoordinator@ucdenver.edu) .The University of Colorado Denver - Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities and all veterans. The University of Colorado is committed to diversity and equality in education and employment.The University of Colorado Denver - Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.QualificationsSpecial Instructions to Applicants: Required Application Materials: To apply, please visit: http://www.cu.edu/cu-careers (https://apptrkr.com/get_redirect.php?id=3315095&targetURL=http://www.cu.edu/cu-careers) and attach: 1. A letter of application which specifically addresses the job requirements and outlines qualifications 2. A current CV/resume 3. List of three to five professional references (we will notify you prior to contacting both on and off-list references) Application Materials Required: Cover Letter, Resume/CV, List of References Application Materials Instructions: Application Deadline: Applications are accepted electronically ONLY at www.cu.edu/cu-careers. Applications will be accepted until finalists are identified, but preference will be given to complete applications received by August 7. 2022. Those who do not apply by this date may or may not be considered.Job Category : Research ServicesPrimary Location : Aurora Department: U0001 -- DENVER & ANSCHUTZ MED CAMPUS - 20066 - SOM-U of Colo Cancer CenterSchedule : Full-timePosting Date : Jul 27, 2022Unposting Date : Ongoing Posting Contact Email: Scott.Leedy@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=3315095&targetURL=Scott.Leedy@cuanschutz.edu) Position Number: 00799830Copyright 2022 Jobelephant.com Inc. All rights reserved.Posted by the FREE value-added recruitment advertising agency (https://www.jobelephant.com/)jeid-52050f35dc562d458ad89c4646a216d4

Keywords: University of Colorado, Aurora , Clinical Research Coordinator Head/Neck Team, Healthcare , Aurora, Colorado